Pharmacological properties
Pharmacodynamics. insulin preparation, identical in structure to human insulin. helps to reduce the level of glucose in the blood, increases its absorption by tissues. active ingredients of the preparation - neutral insulin solution and crystalline protamine-insulin.
Pharmacokinetics. Humodar K25 100P is characterized by a rapid onset and a long-lasting effect. The drug begins to act 30-45 minutes after administration, the maximum effect is achieved after 1-3 hours, the duration of action is 12-16 hours. The duration of the drug's action is approximate; it depends on the dose of Humodar K25 100P and the individual characteristics of the patient's body.
Indication
Diabetes.
Application
Before the first use of the drug, it is necessary to determine sensitivity to the drug by intradermal testing.
The dose and time of injection are set by the doctor individually depending on the diet, blood glucose level, and the patient's needs. When selecting a dose of Humodar K25 100P for adults, the daily insulin requirement is 0.5-1 IU/kg of body weight.
Humodar K25 100R is administered subcutaneously 30-45 minutes before meals. The injection site must be changed after each injection. Humodar K25 100R must not be administered intravenously!
Cartridge. Before use, shake the cartridge with the drug 10 times between the palms of your hands for mixing and turn it 180 ° 10 times. Before inserting the cartridge into the syringe pen, check the homogeneity of the suspension, and if necessary, repeat the procedure again. After mixing, the drug should have the appearance of a homogeneous, cloudy, milky suspension.
Before using the syringe pen, wash your hands and disinfect the rubber membrane of the cartridge.
The cartridge is intended for use in pens only. When installing the cartridge in the pen, follow the manufacturer's instructions.
If there are air bubbles in the cartridge, hold the pen with the needle pointed upwards and tap the cartridge wall to release the bubbles to the surface. Continuing to hold the pen in an upright position, release 2 units of insulin through the needle. Repeat the procedure until the air is out of the cartridge and a drop of the drug appears at the end of the needle. The presence of very small air bubbles is allowed, a large number of bubbles can affect the accuracy of the insulin dose during administration.
Before injecting insulin, thoroughly wipe the skin at the injection site. Insert the needle into the subcutaneous layer to the desired depth. Be careful not to enter a vein. Do not massage the injection site.
Immediately after the injection, remove the needle from the pen. This will ensure sterility and prevent insulin leakage.
For each subsequent injection, repeat the mixing process without removing the cartridge from the pen. Before each injection, make sure that there is a drop of the drug at the end of the needle. If the drug in the cartridge is almost gone and the leading edge of the plunger is on or beyond the colored line, do not use it.
Always check the cartridge label before injecting to make sure the name and prescription of the insulin match those prescribed by your doctor.
Vials. Before the first insulin withdrawal from the vial, remove the plastic cap (first opening control). Before using the drug, the Humodar K25 100P suspension must be well mixed, without foaming, so the vial is rolled between the palms. The suspension should be homogeneous, milky white in color. According to the prescribed dose, draw air into the syringe and inject into the insulin vial (not into the liquid). Turn the insulin vial over together with the syringe and draw the appropriate amount of insulin suspension. Remove air bubbles from the syringe. Disinfect the injection site, form a fold of skin and insert the needle s / c, then slowly inject insulin. After the injection, carefully remove the needle from the skin, press the injection site with a cotton swab and hold for a few seconds.
Do not use the cartridge/vial with the drug if, after mixing, a homogeneous white suspension has not formed, white flakes float, or a white coating in the form of a frozen mass is visible on the bottom or walls of the cartridge. The cartridge is not suitable for refilling or mixing with other drugs and insulins.
Switching to other insulin preparations is done under the supervision of a doctor. The patient must follow all the doctor's instructions: daily insulin dosage, diet, and physical activity.
Contraindication
Severe immediate-type hypersensitivity to insulin. Allergy to any of the components of the drug. Hypoglycemia.
Metabolic disorders, metabolism. Hypoglycemic reaction can develop in case of administration of a high dose of insulin, skipping meals, excessive physical exertion, alcohol consumption. Hypoglycemia is characterized by a decrease in glucose levels of 50 or 40 mg/dl. Symptoms of hypoglycemia: cold sweat, pale skin, nervousness or tremor, anxiety, irritability, unusual fatigue or weakness, loss of orientation, difficulty concentrating, drowsiness, increased hunger, temporary visual impairment, eye refraction, headache, rapid heartbeat. Severe hypoglycemia can lead to loss of consciousness, life-threatening. Incorrect dosage of the drug or discontinuation of treatment (especially for patients with insulin-dependent diabetes mellitus) can lead to hyperglycemia and diabetic ketoacidosis. Symptoms of hyperglycemia: thirst, frequent urination, nausea, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone on the breath. In the first weeks of insulin therapy, insulin edema (swelling of the legs) associated with fluid retention in the body may occur, which disappear on their own.
Immune system disorders. In rare cases, insulin administration leads to the development of an allergy, which manifests itself as a local reaction in the form of redness, swelling or itching in the area of the drug injection. Very rarely, generalized allergic reactions are noted, which are manifested by erosive lesions of the mucous membranes, nausea, chills. Severe manifestations of an allergic reaction to insulin: anaphylactic shock, accompanied by cardiac and respiratory disorders, angioedema. Generalized hypersensitivity reactions are potentially life-threatening. Rarely, patients with diabetes mellitus, who have been taking different types of insulin for many years, may experience insulin resistance (with a daily insulin dose of ≥60 U).
Changes in the skin and subcutaneous tissue. At the beginning of insulin treatment, changes in the appearance of the skin at the injection site may occur: short-term accumulation of fluid in the tissues (transient edema), slight redness of the skin, the changes disappear on their own during further treatment. In the event of the development of significant erythema, accompanied by itching and the appearance of blisters that quickly spread beyond the injection area, as well as other severe hypersensitivity reactions to any of the components of the drug, it is necessary to inform the doctor about them, since such reactions can be life-threatening. The doctor decides on the issue of taking the necessary measures. Atrophy or hypertrophy of fatty tissue (lipodystrophy) may occur at the injection site. Constantly changing the injection site makes it possible to reduce the severity of these manifestations or avoid them altogether during further treatment.
Neurological disorders: Reversible peripheral neuropathy may occur.
If any adverse reaction occurs, you should consult a doctor immediately!
Special instructions
In case of incorrect dose selection or drug replacement, as well as with irregular use of this drug or irregular meal intake, excessive fluctuations in blood glucose levels are possible, primarily in the downward direction, which reduce the ability to influence the reaction rate when driving vehicles or working with other mechanisms. This occurs in the initial period of treatment, as well as with simultaneous use of alcohol or drugs that act on the CNS (see interactions).
Sometimes complications arise due to damage to the innervation apparatus of the skin by the injection needle or chemicals contained in insulin preparations as preservatives.
Precautions for use. Any change in insulin preparations should be made with caution and only under medical supervision. Changes in concentration, manufacturer, type (rapid-acting, intermediate-acting, slow-acting, etc.), type (animal, human, human insulin analogues), or method of production (rDNA-derived as opposed to animal-derived insulin) may require a change in dosage.
Pregnancy and breastfeeding. Insulin does not cross the placental barrier, so there are no restrictions on the treatment of diabetes during pregnancy. Insulin requirements usually decrease in the first trimester of pregnancy and increase significantly in the second and third trimesters. Immediately after delivery, insulin requirements decrease sharply, which increases the risk of hypoglycemia. However, insulin requirements then quickly return to baseline. Insulin dosage or diet may need to be adjusted while breastfeeding.
Children: There is insufficient experience with the use of the drug in children.
Interactions
Additional prescription of other medicines may increase or decrease the severity of the effect of insulin on blood glucose levels. Therefore, simultaneous use of insulin with other medicines is possible under the supervision of a doctor.
A decrease in the severity of insulin action is possible during simultaneous use with chlorprothixene, diazoxide, hormonal contraceptives, diuretics (saluretics), heparin, isoniazid, corticosteroids, lithium carbonate, nicotinic acid, phenolphthalein, phenothiazine derivatives, phenytoin, thyroid hormones, sympathomimetic agents, and tricyclic antidepressants.
Patients who simultaneously receive insulin and clonidine, reserpine, or salicylates may experience both a decrease and an increase in the severity of insulin action.
Drinking alcohol can cause your blood glucose levels to drop dangerously low.
Overdose
Causes: absolute overdose of insulin, drug replacement, skipping meals, vomiting, diarrhea, physical exertion, diseases that lead to a decrease in the need for insulin (kidney and liver diseases, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site (for example, skin of the abdomen, forearm, thigh), as well as the interaction of insulin with other agents that lead to a sharp decrease in blood glucose levels. If a diabetic patient notices signs of hypoglycemia, he can independently eliminate this condition by taking glucose or sugar (preferably in the form of a solution) or food containing a large amount of sugar or carbohydrates. For this purpose, ≥20 g of glucose (grape sugar) should be constantly carried with him. If an immediate increase in glucose levels is not noted, it is necessary to urgently call a doctor. This condition is especially dangerous for patients with impaired cerebral circulation and for patients with severe coronary heart disease.
In more severe conditions caused by a decrease in blood glucose levels, an intravenous injection of glucose, administered by a doctor, or an intramuscular injection of glucagon is necessary. If after this the patient is again capable of independent activity, he needs to take food.
Storage conditions
At a temperature of 2-8 °C. Do not allow freezing, avoid direct contact of the cartridge with the freezer compartment or cold storage.
Store the used cartridge for up to 3 weeks at room temperature, away from direct heat and light.
The used insulin vial can be stored for 6 weeks at room temperature (not above 25°C) away from direct heat and light.
